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Clinical Trials in France / NCT07735559
Starting soon Not applicable

SAFE-iPS - France's First Hospital-based Platform for the Production of Induced Pluripotent Stem Cells for the Regenerative Medicine of the Future

NCT07735559 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Montpellier
Phase
Not applicable
Started
2026-11
Last updated
2026-07-30

Condition(s) studied

Regenerative MedicineInduced Pluripotent Stem Cells (iPSC) Production

Investigational drug(s) / intervention(s)

Blood Collection for iPSC Generation

Blood Collection for iPSC Generation: The study includes telephone and on-site visits at Montpellier University Hospital. Participants will undergo blood collection procedures, including approximately 24 mL for eligibility assessment and approximately 54 mL of heparinized blood for the generation of clinical-grade induced pluripotent stem cell (iPSC) lines on the SAFE-iPS platform.

Study summary

The objective of the study is to establish the first French hospital-based Good Manufacturing Practice (GMP)-compliant platform for the production of clinical-grade induced pluripotent stem cells (iPSCs) for future regenerative medicine applications.

The primary objective is to generate, via the SAFE-iPS platform, 4 clinical-grade iPSC lines derived from peripheral blood samples taken from:

* Two healthy male volunteers
* Two healthy female volunteers

These 4 iPSC lines will undergo comprehensive quality assessment including:

* Expression of pluripotency markers
* Genomic stability assessment
* Absence of residual Sendai viral integration
* Technical reproducibility assessment
* Manufacturing efficiency assessment
* Preliminary medico-economic evaluation This project aims to demonstrate that the SAFE-iPS manufacturing process can be successfully transferred to a hospital Good Manufacturing Practice (GMP) environment and can reproducibly generate clinical-grade iPSC lines meeting international quality standards for future regenerative medicine applications. It also aims to establish the first French public hospital platform dedicated to routine GMP production of clinical-grade iPSCs.

Eligibility

Sex
ALL
Min age
18 Years
Max age
35 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age ≥ 18 years and ≤ 35 years * No medical contraindication to a 54 mL blood sample collection * Negative viral serology for: * Human Immunodeficiency Virus (HIV) * Hepatitis B Virus (HBV) * Hepatitis C Virus (HCV) * Human T-lymphotropic Virus type 1 (HTLV-1) * A participant who agrees to have their anonymized biological samples and cell lines stored in a biological sample collection for other research purposes (including genetic research) Exclusion Criteria: * Any active medical condition * Any ongoingl treatment * Subjects who cannot read and/or write * Inability to ensure participant during the study period * Participation in another clinical trial or administration of an off-label medication that could interfere with blood test results. * Participation in another research protocol involving biological sampling that limits the number of mL to be collected. * Failure to obtain informed consent * Not enrolled in a social security program, * Subject participating in another research study with an ongoing exclusion period * Protected populations under the French Public Health Code (women who are giving birth, breastfeeding, or pregnant; subjects deprived of liberty by judicial or administrative decision; adults under legal protection (under any form of guardianship))

Primary outcome measure(s)

  • Successful generation of functional induced pluripotent stem cell (iPSC) lines — upon completion of reprogramming and full validation, within ≤ 60 days post-transfection
    The primary outcome of the study is the successful production of four (4) functional human induced pluripotent stem cell (iPSC) lines, comprising two (2) male-derived and two (2) female-derived lines, validated according to international pluripotency standards

Trial sites (1)

FacilityCityRegionStatus
University Hospital Montpellier Montpellier France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07735559 on ClinicalTrials.gov ↗ ← All trials in France